Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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Oligonucleotide Scale-Up: Six Things Every Sponsor Needs To Know

From impurity control to technology transfer governance, these practical lessons will help sponsors navigate the realities of oligonucleotide manufacturing scale-up.

Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures
EMA's New Guideline For Synthetic Peptides: A More Explicit CMC Playbook For A Growing Therapeutic Class

GUEST COLUMNISTS

Is Your AI Model Trustworthy And Credible In GMP Processes?
Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.
May 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Setting The Tone For A Fill/Finish Engagement Program
The initial 90 days of a fill/finish CDMO partnership establish lasting communication patterns, clarify mutual responsibilities, and test problem-solving capabilities critical to program success.
FDA's Guidance On Cell And Gene CMC Codifies Flexibility
The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis.
Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline?
Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.
Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
Let's debunk the misconception that robotics, gloveless systems, or fully closed isolators automatically result in Annex 1 compliance for cell and gene therapies.
Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.
A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

PHARMA OUTSOURCING WHITE PAPERS

Improvements In ADC Efficacy And Stability
Antibody–drug conjugates link antibodies to potent toxins, but increased hydrophobicity impairs stability, manufacturing, and PK, spurring interest in hydrophilic linker strategies.

Antibody Drug Conjugates Re-Emergence Of An Old Modality
Antibody-drug conjugates link targeted antibodies with potent drugs to treat cancer more precisely, though challenges remain in stability, conjugation, and scalable production.
Accelerating An Innovative High Potency Oncology Therapy To Market
Learn how disciplined containment, proactive risk management, and collaboration accelerate complex oncology programs under tight timelines while protecting quality, safety, and global launch readiness.
Better, Safer Science Through Proper Detergent Selection And Cleaning
Enforce reliable lab results by improving washer performance, detergent selection, and rinsing to prevent residues, cross-contamination, and spotting—supporting reproducibility and compliance.
Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility
The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
Next Generation Sequencing In Viral Safety Testing
Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.